- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07680231
Smartphone Versus Back Range of Motion: Validity and Reliability in Lumbar Range of Motion Assessment
29 juni 2026 uppdaterad av: Loay Akmal Ali, Cairo University
Clinimetric Properties of Smartphone Application as a Suitable Alternative to Back Range of Motion Device in Assessing the Back Range of Motion
This study aims to investigate the clinimetric properties of the iPhone Level application as a suitable alternative to the Back Range of Motion device in assessing lumbar range of motion, including flexion, extension, and lateral flexion.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Range of motion measurement is vital in physiotherapy for assessing deficits, establishing diagnoses, and planning interventions.
Digital advancements now allow Range of motion assessment through devices and applications, such as the back range of motion, which is a gold standard for measuring lateral flexion due to its validity.
Furthermore, studies indicate that the iPhone Level app effectively measures Range of motion in various joints, demonstrating good reliability and validity.
This study aims to evaluate the reliability and concurrent validity of the iPhone Level application specifically for measuring lumbar flexion, extension, and side bending Range of motion.
Studietyp
Observationell
Inskrivning (Faktisk)
120
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Giza, Egypten, 12613
- Cairo University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Testmetod
Sannolikhetsprov
Studera befolkning
Healthy University Students with normal BMI Healthy Male university students
Beskrivning
Inclusion Criteria:
- Age 18-25 years old
- Healthy Male university students
- All participants have normal BMI
Exclusion Criteria:
- Recent back, pelvic, or abdominal surgeries, traumatic injury to the back .
- Lower limb deformities, e.g., leg length discrepancy.
- Adolescent idiopathic scoliosis
- Any overweight or obese participants
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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assessment of flexion and extension range of motion using inclinometer
Tidsram: at baseline
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During lumbar flexion and extension measurements using the Back Range of Motion (BROM) device, patients stand upright with extended knees and feet approximately 17 centimeters apart.
For flexion, they bend forward to touch the floor, while for extension, they bend backward with crossed arms.
An inclinometer is secured over the sacrum, and its position is centered to record readings in degrees.
An L-shaped slide arm measures the distance between the T12 and S1 spinous processes.
The device isolates lumbar motion from pelvic motion, and the stationary flexion/extension unit minimizes errors, enhancing measurement accuracy.
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at baseline
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assessment of lateral flexion range of motion using inclinometer
Tidsram: at baseline
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For measuring lumbar lateral flexion, the subject's sides are parallel to a wall to prevent compensatory forward trunk flexion.
An inclinometer is secured over the sacral region at S1, using a belt for stability.
A gravity goniometer is placed on the upper thoracic region to capture trunk angular displacement during side bending.
The inclinometer is levelled and zeroed before movement, allowing for precise measurement of lateral lumbar movement while reducing thoracic and pelvic compensations.
Accurate placement of the device is essential for reliable results.
The subject slides their hand down the thigh, keeping weight on the opposite leg to ensure the measurement reflects true lateral flexion.measures]
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at baseline
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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assessment of flexion and extension range of motion using smartphone
Tidsram: at baseline
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To measure lumbar flexion range of motion (ROM) using the iPhone Level app, participants are positioned standing upright with feet shoulder-width apart.
T12-L1 and S1-S2 spinal levels are identified through palpation and marked on the skin.
The iPhone is placed at these levels to record angles during maximum lumbar flexion.
Total lumbar flexion ROM is calculated by subtracting the angle at S1-S2 from T12-L1.
Subjects perform maximum lumbar flexion and extension with straight knees, and measurements are taken across three trials.
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at baseline
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assessment of lateral flexion range of motion using smartphone
Tidsram: at baseline
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During the measurement of lumbar side bending using the iPhone Level application, the subject will stand in a neutral upright position with feet shoulder-width apart and hands placed on the hips to prevent arm movement from influencing the measurement.
The spinous processes of T12 and S2 are identified and marked on the skin.
The iPhone is first placed and zeroed at the T12 level, and the subject is instructed to bend sideways (toward one side) as far as possible without lifting the heels or rotating the trunk.
The device remains aligned at T12 to capture the angular displacement.
The same procedure is repeated with the device positioned at S2, and the final lumbar side bending range of motion is calculated by subtracting the angle at S2 (pelvic movement) from that at T12 (trunk movement).
This method isolates lumbar lateral flexion and has shown good reliability and validity in clinical settings
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at baseline
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Samarbetspartners och utredare
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Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2025
Primärt slutförande (Faktisk)
1 mars 2026
Avslutad studie (Faktisk)
12 maj 2026
Studieregistreringsdatum
Först inskickad
14 juni 2026
Först inskickad som uppfyllde QC-kriterierna
29 juni 2026
Första postat (Faktisk)
2 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P.T.REC/012/006199
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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